United States Government Accountability Office

GAO Testimony 

Before the Subcommittee on Oversight 

and Investigations, Committee on Energy 

and Commerce, U.S. House of 

Representatives

PRESCRIPTION DRUGS

Enhanced Efforts and 

Better Agency Coordination 

Needed to Address Illegal 

Importation 

Statement of Richard M. Stana, Director 

Homeland Security and Justice Issues 

For Release on Delivery

Expected at 1:00 p.m. EST 

Tuesday, December 13, 2005

 

GAO-06-175T 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

December 2005

PRESCRIPTION DRUGS 

Enhanced Efforts and Better Agency 

Coordination Needed to Address Illegal 

Importation 

Highlights of GAO-06 175T, a testimony 

before the Subcommittee on Oversight 

and Investigations, Committee on Energy 

and Commerce, U.S. House of 

Representatives 

This testimony summarizes a GAO 

report on federal efforts to address 

the importation of prohibited 

prescription drugs through

international mail and carrier

facilities for personal use. U.S. 

Customs and Border Protection

(CBP), in the Department of

Homeland Security (DHS), and the

Food and Drug Administration 

(FDA), in the Department of Health

and Human Services (HHS), work

with other federal agencies at 

international mail and express 

carrier facilities to inspect for and 

interdict these drugs. This 

testimony addresses (1) available 

data about the volume and safety of 

these drugs, (2) the procedures and 

practices used to inspect and 

interdict them, (3) factors affecting

federal efforts to enforce the laws 

governing these drugs, and (4) 

federal agencies’ efforts to 

coordinate enforcement of the 

prohibitions on personal 

importation of these drugs. 

What GAO Recommends

GAO recommends that (1) CBP and 

other task force agencies develop a 

strategic framework to enhance

their enforcement efforts and (2) 

HHS assess the effect of modifying 

the requirement that FDA notify

addressees about unapproved drug

imports. DHS and most task force 

agencies generally supported the

idea of a strategic framework. HHS 

agreed to assess modifying the 

notification requirement, and the

U.S. Postal Service said that any 

proposal should consider 

international postal obligations. 

The information currently available on the safety of illegally imported 

prescription drugs is very limited, and neither CBP nor FDA systematically 

collects data on the volume of these imports. Nevertheless, on the basis of 

their own observations and limited information they collected at some mail 

and carrier facilities, both CBP and FDA officials said that the volume of 

prescription drugs imported into the United States is substantial and 

increasing. FDA officials said that they cannot assure the public of the safety 

of drugs purchased from foreign sources outside the U.S. regulatory system. 

FDA has issued new procedures to standardize practices for selecting 

packages for inspection and making admissibility determinations. While 

these procedures may encourage uniform practices across mail facilities, 

packages containing prescription drugs continue to be released to the 

addressees. CBP has also implemented new procedures to interdict and 

destroy certain imported controlled substances, such as Valium. CBP 

officials said the new process is designed to improve their ability to quickly 

handle packages containing these drugs, but they did not know if the policy 

had affected overall volume because packages may not always be detected. 

GAO identified three factors that have complicated federal enforcement of 

laws prohibiting the personal importation of prescription drugs. First, the 

volume of imports has strained limited federal resources at mail facilities. 

Second, Internet pharmacies can operate outside the U.S. regulatory system 

and evade federal law enforcement actions. Third, current law requires FDA 

to give addressees of packages containing unapproved imported drugs 

notice and the opportunity to provide evidence of admissibility regarding 

their imported items. FDA and HHS have testified before Congress that this 

process placed a burden on limited resources. In May 2001, FDA proposed to 

the HHS Secretary that this legal requirement be eliminated, but according to 

FDA and HHS officials, as of July 2005, the Secretary had not responded with 

a proposal. FDA officials stated that any legislative change might require 

consideration of such issues as whether to forgo an individual’s opportunity 

to provide evidence of the admissibility of the drug ordered. 

Prior federal task forces and working groups had taken steps to deal with 

Internet sales of prescription drugs since 1999, but these efforts did not 

position federal agencies to successfully address the influx of these drugs 

imported from foreign sources. Recently, CBP has organized a task force to 

coordinate federal agencies’ activities to enforce the laws prohibiting the 

personal importation of prescription drugs. The task force’s efforts appear to 

be steps in the right direction, but they could be enhanced by establishing a 

strategic framework to define the scope of the problem at mail and carrier 

facilities, determine resource needs, establish performance measures, and 

evaluate progress. Absent this framework, it will be difficult to oversee task 

force efforts; hold agencies accountable; and ensure ongoing, focused 

attention to the enforcement of the relevant laws. 

www.gao.gov/cgi-bin/getrpt?GAO-06-175T-.

To view the full product 

click on the link above. 

For more information, contact Richard Stana 

at (202) 512-8777 or StanaR@gao.gov. 
Mr. Chairman and Members of the Subcommittee: 

I appreciate the opportunity to provide a summary of our recent report on

federal agencies’ efforts to address the importation of prohibited 

prescription drugs through international mail and carrier facilities.1

The advent of online Internet pharmacy services in early 1999, enabled 

American consumers to order over the Internet a range of prescription 

drugs from controlled substances,2

 such as Valium, to noncontrolled 

prescription drugs intended to improve an individual’s quality of life by

addressing non-life-threatening conditions such as baldness, impotence, 

and obesity. The broad reach and access of the Internet allow the easy 

creation of online pharmacies that anonymously traverse state and 

national borders to prescribe, sell, and dispense prescription drugs 

without complying with traditional state or federal regulatory safeguards. 

Under current law, the importation of prescription drugs, both controlled 

and noncontrolled, for personal use is illegal, with few exceptions. In 

 1

See GAO, Prescription Drugs: Strategic Framework Would Promote Accountability and

Enhance Efforts to Enforce the Prohibitions on Personal Importation, GAO-05-372

(Washington, D.C.: September 8, 2005). 

Page 1 GAO-06-175T 
recent years, Congress and others have debated whether Americans 

should be allowed to purchase drugs from pharmacies located in foreign 

countries. However, currently, consumers could be violating federal law, 

unknowingly or intentionally, by having drugs shipped, in effect, imported, 

into the United States through the international mail and private carriers. 

Two acts specifically regulate the importation of prescription drugs into 

the United States. That is, all prescription drugs offered for import must 

meet the requirements of the Federal Food, Drug, and Cosmetic Act, and

those that are controlled substances also must meet the requirements of 

the Controlled Substances Import and Export Act. Prescription drugs 

imported for personal use generally do not meet these requirements. 

Several federal agencies have responsibility for regulating the importation 

of prescription drugs through the international mail and private carriers. 

They include the Department of Homeland Security’s (DHS) U.S. Customs 

and Border Protection (CBP), which can inspect international mail and 

packages for potentially illegal drugs entering the United States through 

the U.S. Postal Service’s (USPS) international mail facilities or private 

carriers; the Department of Health and Human Services’ (HHS) Food and 

 2

The Controlled Substances Act establishes a classification structure for certain drugs and 

chemicals that are designated as controlled substances. This structure places such 

substances in one of five schedules, based on their medicinal value, risk to public health,

and potential for abuse and addiction, among other factors. Schedule I is reserved for the

most dangerous drugs that have no currently accepted medical use, such as heroin and

ecstasy. Controlled substances that may be prescribed by a physician or used in medical 

facilities fall in schedules II through V (e.g., Valium). For certain law enforcement 

purposes, however, schedule II drugs are treated more like schedule I drugs. 

Page 2 GAO-06-175T 
Drug Administration (FDA), which is responsible for ensuring the safety, 

effectiveness, and quality of domestic and imported drugs; the Department 

of Justice’s Drug Enforcement Administration (DEA), which regulates 

controlled substances; and the Department of Homeland Security’s U.S. 

Immigration and Customs Enforcement (ICE), which has law enforcement 

responsibilities that include investigations of prescription drugs coming 

into the United States through the mail and express carriers. Also, the 

Office of National Drug Control Policy (ONDCP) formulates the nation’s 

drug control strategy and addresses policy issues concerning the illegal 

distribution of controlled substances, as its authority does not extend over 

noncontrolled substances. 

This statement presents a summary of our latest work on federal efforts to 

enforce prohibitions on personal importation of prescription drugs 

through the international mail and carrier facilities, which was requested 

by the Chairman of the Senate Permanent Subcommittee on 

Investigations, Committee on Homeland Security and Governmental 

Affairs and the Ranking Minority Member of the House Energy and 

Commerce Committee. My testimony today, requested by the Chairman of 

this Subcommittee, provides a summary of our report and will focus on 

the following issues: 

Page 3 GAO-06-175T 
• what available data show about the volume and safety of prescription 

drugs imported into the United States for personal use through the 

international mail and private carriers, 

• what procedures and practices are used at selected facilities to inspect 

and interdict prescription drugs unapproved for import, 

• what factors affect federal agency efforts to enforce the prohibition on 

prescription drug importation for personal use through international 

mail and carrier facilities, and 

• what efforts federal agencies have undertaken to coordinate the 

enforcement of the prohibitions on personal importation of 

prescription drugs. 

Our report on illegal prescription drug importation notes that the 

information currently available on the safety of illegally imported 

prescription drugs is very limited, and neither CBP nor FDA systematically

collects data on the volume of these imports. Nevertheless, on the basis of 

their own observations and limited information they have collected at 

some mail and carrier facilities, both CBP and FDA officials said the 

volume of prescription drugs imported into the United States is 

substantial. For example, a December 2004 HHS report states that 

approximately 10 million packages containing prescription drugs enter the 

United States annually from all over the world. However, this estimate has 

limitations, being partially based on extrapolations from limited FDA 

Summary 

Page 4 GAO-06-175T 
observations at international mail branch facilities. Without reliable 

estimates of the volume of importation of prescription drugs, federal 

agencies cannot determine the full scope of the importation issue, which is 

of particular concern because of access to potentially unsafe or risky 

drugs, including highly addictive controlled substances. With regard to 

safety, the FDA officials told us that they cannot assure the public of the 

safety and quality of drugs purchased from foreign sources that are largely 

outside the U.S. regulatory system. Consistent with these concerns, in 

June 2004, we reported that a sample of drugs purchased from some 

foreign-based Internet pharmacies posed safety risks for consumers.3

Regarding the practices used at the mail and carrier facilities we visited to

inspect packages and interdict prohibited prescription drugs, our report 

states that both FDA’s and CBP’s procedures are evolving. FDA issued 

procedures in August 2004 to standardize the selection of packages by

CBP and the forwarding of them to FDA for inspection. These procedures 

include guidelines for inspecting the packages and making admissibility 

determinations. However, under the current procedures, similar to 

previous practices, many packages that contain prescription drugs 

prohibited for import are released to addressees. For example, packages 

 3

See GAO, Internet Pharmacies: Some Pose Safety Risks for Consumers, GAO-04-820

(Washington, D.C.: June 17, 2004) and GAO, Internet Pharmacies: Some Pose Safety Risks

for Consumers and Are Unreliable in Their Business Practices, GAO-04-888T 

(Washington, D.C.: June 17, 2004). 

Page 5 GAO-06-175T 
that contain prescription drugs prohibited for import that have not been 

processed by FDA inspectors at the end of each workday are returned by

FDA for delivery by USPS to the recipient. CBP has also implemented a 

new policy to expedite its handling of schedule III through V controlled 

substances imported as prescription drugs. Until recently, CBP was 

required to seize and begin forfeiture proceedings on packages of such 

controlled substances it detected—a process CBP considered to be timeconsuming given the volume of controlled substances entering some 

facilities. In September 2004, CBP determined it could treat schedule III 

through V controlled substances as abandoned property, thereby (1) 

reducing the amount of information recorded about the drugs and (2) 

enabling CBP to destroy the drugs 30 days after notifying the addressee 

that the drugs would be treated as abandoned property if not claimed. 

In our report, we also identify three factors beyond inspection and 

interdiction issues that have complicated federal efforts to enforce laws 

prohibiting the importation of prescription drugs for personal use. First, 

the volume of importation has strained federal resources at the mail and 

carrier facilities. According to officials we contacted, agencies have 

multiple priorities, which can constrain the resources they are able to 

allocate to the inspection and interdiction of prescription drugs and 

controlled substances imported through mail and carrier facilities. Second, 

the attributes of Internet pharmacies have posed challenges to law 

Page 6 GAO-06-175T 
enforcement efforts for multiple reasons. For example, Internet sites can

be installed, moved, or removed in a short period of time, making it 

difficult for law enforcement agencies to identify, track, monitor, or shut 

down those sites that operate illegally. Additionally, legal and practical 

considerations can limit the nature and extent to which commercial firms 

(e.g., Internet providers and credit card organizations) can assist in federal

law enforcement actions. Third, the notification process in current law 

requiring FDA to hold packages containing items that appear unapproved 

for import and give the addressee the opportunity to provide evidence of 

admissibility is, according to FDA officials, time-consuming ⎯ taking up to

30 days per import ⎯ and can hinder their ability to quickly process 

packages containing potentially unapproved prescription drugs. FDA and 

the Secretary of Health and Human Services have expressed concerns 

about this process during testimony before Congress. However, FDA 

officials told us that any legislative change might necessitate consideration 

of some complicated issues, including whether the government would 

want to forgo an individual’s opportunity to provide evidence of 

admissibility for the drug(s) that had been ordered, or what imported 

prescription drugs and other imported products within FDA’s jurisdiction 

should be covered by the new law. In addition, USPS indicated that any 

discussion of options to expedite the processing and disposition of 

Page 7 GAO-06-175T 
prescription drugs should consider international postal obligations 

established by the Universal Postal Union (UPU).4

We also report that CBP has organized a task force to coordinate the 

activities of federal agencies responsible for enforcing laws prohibiting the 

personal importation of prescription drugs. Among other things, the task

force has performed joint operations to gather data on the type and source 

of unapproved drugs entering international mail facilities and developed 

public service campaigns to inform the public about the risks of buying 

prescription drugs from Internet providers in foreign countries. Although

the task force appears to be a step in the right direction, efforts to address 

many of the challenges facing these agencies could be further enhanced if 

the task force established a strategic framework to promote accountability 

and guide resource and policy decisions. Our past work has shown that a 

strategic framework is particularly useful in addressing problems, such as 

prescription drug importation, that are national in scope and involve 

multiple agencies with varying jurisdictions. Without such a strategic 

framework, it will be difficult for agency officials and congressional 

 4

UPU is a specialized agency of the United Nations governing international postal services. 

According to the USPS, the Universal Postal Convention establishes a general rule that

undeliverable items are to be returned to sender. UPU regulations provide that where an

item can neither be delivered to the addressee nor returned to the sender, the Postal 

Service must notify the postal administration of origin of how the item was dealt with, 

including indicating the prohibition under which the item falls. USPS noted that this is 

particularly important with respect to registered or insured mail for which the Postal 

Service can be held financially responsible if it is not delivered or returned. 

Page 8 GAO-06-175T 
decision makers to oversee the overall federal effort, hold agencies 

accountable for their individual efforts, adjust to changing conditions, and 

ensure consistent and focused attention to the enforcement of 

prescription drug importation laws. 

Accordingly, our report recommends that the CBP Commissioner, in 

concert with other agencies responsible for enforcing these laws, develop 

and implement a strategic framework that, at a minimum, includes 

establishing an approach to more reliably estimate the volume of 

prohibited prescription drugs imported through international mail and 

carrier facilities; determine resource needs and target resources based on 

priorities; establish performance measures and milestones; and evaluate 

progress, identify barriers to achieving goals, and suggest modifications.

DEA and ONDCP generally agreed with this recommendation. DHS 

generally agreed with the contents of our report and said that CBP is 

convening a task force meeting to discuss it. While generally concurring 

with this recommendation, HHS questioned the need to include an 

approach to estimate the volume of unapproved drugs entering the 

country, believing its current estimates to be valid. We believe that 

developing more systematic and reliable volume estimates might position 

agencies to better define the scope of the problem so that decision makers 

can make informed choices about resources. Considering FDA’s 

continuing concern about the statutory notification requirement, we also 

Page 9 GAO-06-175T 
recommend that the Secretary of HHS assess the ramifications of 

removing or modifying the requirement, report the assessment results, 

and, if appropriate, recommend changes to Congress. HHS generally 

agreed with this recommendation; USPS noted that discussions of such 

options must consider international postal obligations. 

All international mail and packages entering the United States through the 

U.S. Postal Service and private carriers are subject to potential CBP 

inspection at the 14 USPS international mail facilities and 29 express 

consignment carrier facilities operated by private carriers located around 

the country. CBP inspectors can target certain packages for inspection or 

randomly select packages for inspection. CBP inspects for, among other 

things, illegally imported controlled substances, contraband, and items—

like personal shipments of noncontrolled prescription drugs—that may be 

inadmissible. CBP inspections can include examining the outer envelope 

of the package, using X-ray detectors, or opening the package to physically 

inspect the contents. Each year the international mail and carrier facilities

process hundreds of millions of pieces of mail and packages. Among these 

items are prescription drugs ordered by consumers over the Internet, the

importation of which is prohibited under current law, with few exceptions. 

Background 

Page 10 GAO-06-175T 
Two acts—the Federal Food, Drug, and Cosmetic Act and the Controlled 

Substances Import and Export Act—specifically regulate the importation 

of prescription drugs into the United States. Under the Federal Food, 

Drug, and Cosmetic Act, as amended, FDA is responsible for ensuring the 

safety, effectiveness, and quality of domestic and imported drugs and may 

refuse to admit into the United States any drug that appears to be 

adulterated, misbranded, or unapproved for the U.S. market as defined in

the act.5

 Under the act and implementing regulations, this includes foreign 

versions of FDA-approved drugs if, for example, neither the foreign 

manufacturing facility nor the manufacturing methods and controls were

reviewed by FDA for compliance with U.S. statutory and regulatory 

standards. The act also prohibits reimportation of a prescription drug 

manufactured in the United States by anyone other than the original 

manufacturer of that drug. According to FDA, prescription drugs imported 

by individual consumers typically fall into one of these prohibited 

categories. However, FDA has established a policy that allows local FDA 

officials to use their discretion to not interdict personal prescription drug 

imports that do not contain controlled substances under specified 

circumstances, such as importing a small quantity for treatment of a 

 5

An unapproved drug includes one that has not been demonstrated to be safe and effective 

and for which the manufacturing facility, methods, and controls have not been shown to 

meet FDA standards. Failure to meet other statutory and regulatory standards relating to 

labeling, handling, and packaging may result in a drug being considered adulterated or

misbranded. See 21 U.S.C. §§ 351, 352, 355. 

Page 11 GAO-06-175T 
serious condition, generally not more than a 90-day supply of a drug not 

available domestically.6 The importation of prohibited foreign versions of 

prescription drugs like Viagra (an erectile dysfunction drug) or Propecia (a 

hair loss drug), for example, would not qualify under the personal 

importation policy because approved versions are readily available in the 

United States. 

In addition, the Controlled Substances Import and Export Act, among 

other things, generally prohibits personal importation of those 

prescription drugs that are controlled substances, such as Valium. Under 

the act, shipment of controlled substances to a purchaser in the United 

States from another country is only permitted if the purchaser is registered 

with DEA as an importer and is in compliance with the Controlled 

Substances Import and Export Act and DEA requirements. As outlined in 

the act, it would be difficult, if not impossible, for an individual consumer 

 6

According to the policy, other conditions should be met as well, such as (1) provision of 

the name and address of the doctor licensed in the United States responsible for the

importer’s treatment with the product or evidence that the product is for continuation of

treatment begun in a foreign country and (2) the absence of any known commercialization

or promotion to persons residing in the United States by those involved in the distribution 

of the product at issue. Alternatively, in the case of a drug that is not for a serious

condition, the policy also permits FDA officials to use their discretion to allow importation 

of that drug if the intended use is identified and the product is not known to represent a

significant health risk. A complete description of FDA’s personal importation policy can be

found in chapter 9 of FDA’s Regulatory Procedures Manual, which is available on the

agency’s Web site. 

Page 12 GAO-06-175T 
seeking to import a controlled substance for personal use to meet the 

standards for registration and related requirements.7

CBP is to seize illegally imported controlled substances it detects on 

behalf of DEA.8 CBP may take steps to destroy the seized and forfeited 

substance or turn the seized substance over to other federal law 

enforcement agencies for further investigation.9

 CBP is to turn over 

packages suspected of containing prescription drugs that are not 

controlled substances to FDA.10 FDA investigators may inspect such 

packages and hold those that appear to be adulterated, misbranded, or 

unapproved, but must notify the addressee and allow that individual the 

opportunity to present evidence as to why the drug should be admitted 

into the United States.11 If the addressee does not provide evidence that 

overcomes the appearance of inadmissibility, then the item is refused 

admission and returned to the sender. 

 7

The act and implementing regulations permit an individual traveler under certain 

circumstances to carry a personal use quantity of a controlled substance (except a

substance in schedule I) across the U.S. border, but they do not make a similar exception

for importation by mail or private carrier. 

8

See 19 U.S.C. § 1595a(c)(1)(B); 19 C.F.R. §§ 162.23, 145.59, 145.58, 12.36. Controlled 

substances in schedules I and II are subject to summary forfeiture without notice, but those 

in schedule III through V are not. 

9

See 19 C.F.R. §§ 162.31, 162.32, 162.45, 162.45a, 162.46, 162.47, 162.63. 

10See 21 U.S.C. § 381(a); 19 C.F.R. §§ 12.1(a), 145.57; see also Chapter 9 of FDA’s 

Regulatory Procedures Manual, Subchapter Coverage of Personal Importations, “Mail 

Shipments” http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html.

11See 21 U.S.C. § 381(a); 21 CFR §1.94. 

Page 13 GAO-06-175T 
Investigations that may arise from CBP and FDA inspections may fall 

within the jurisdiction of other federal agencies. DEA, ICE, and FDA 

investigators have related law enforcement responsibilities and may 

engage in investigations stemming from the discovery of illegally imported 

prescription drugs. Although USPS’s Inspection Service does not have the 

authority, without a federal search warrant, to open packages suspected of

containing illegal drugs, it may collaborate with other federal agencies in 

certain investigations. Also, ONDCP is responsible for formulating the 

nation’s drug control strategy and has general authority for addressing 

policy issues concerning the illegal distribution of controlled substances. 

ONDCP’s authority does not, however, include prescription drugs that are 

not controlled substances. 

My statement will now focus on what the available data show about the 

volume and safety of prescription drugs imported into the United States 

for personal use through the international mail and private carriers. 

The Volume of 

Prescription Drug 

Imports Is Unknown 

but Believed to Be 

Substantial, and the 

Safety of These Drug 

Imports Is Not 

Assured 

Page 14 GAO-06-175T 
In our report, we state that CBP and FDA do not systematically collect 

data on the volume of prescription drugs and controlled substances they 

encounter at the mail and carrier facilities. CBP and FDA officials have 

said that in recent years they have observed increasingly more packages 

containing prescription drugs being imported through the mail facilities, 

but neither agency has complete data to estimate the volume of 

importation. FDA officials told us that CBP and FDA currently have no 

mechanism for keeping an accurate count of the volume of illegally 

imported drugs, because of the large volume of packages arriving daily 

through the international mail and carriers. Furthermore, FDA officials 

told us that FDA did not routinely track items that contained prescription 

drugs potentially prohibited for import that they released and returned for 

delivery to the recipient. However, they said that FDA had begun gathering 

from the field information on the imported packages it handles, but as of 

July 2005, this effort was still being refined. 

CBP and FDA Do Not 

Know the Scope of 

Prohibited Prescription 

Drug Importation, but 

They Believe it to Be 

Substantial 

We also report that CBP and FDA, in coordination with other federal 

agencies, have conducted special operations targeted to identify and tally 

the packages containing prescription drugs imported through a particular 

facility during a certain time period and to generate information for 

possible investigation. The limited data collected have shown wide 

variations in volume. For example, at one mail facility CBP officials 

estimated that approximately 3,300 packages containing prescription 

Page 15 GAO-06-175T 
drugs entered the facility in 1 week and at another mail facility CBP 

officials estimated that 4,300 such packages entered the facility in 1 day. 

While these data provide some insight regarding the number of packages 

containing prescription drugs at a selected mail facility during a certain 

time period, the data are not representative of other time periods or 

projectable to other facilities. 

Our report also notes that during congressional hearings over the past 4 

years, FDA officials, among others, have presented estimates of the 

volume of prescription drugs imported into the United States through mail 

and express carrier facilities ranging from 2 million to 20 million packages 

in a given year. Each estimate has its limitations; for example, some 

estimates were extrapolations from data gathered at a single mail facility. 

More recently, a December 2004 HHS report stated that approximately 10

million packages containing prescription drugs enter the United States—

nearly 5 million packages from Canada and another 5 million mail 

packages from other countries.12 However, these estimates also have 

limitations, being partially based on extrapolations from limited FDA 

 12HHS Task Force on Drug Importation, Report on Prescription Drug Importation, 

Department of Health and Human Services, December 2004. 

Page 16 GAO-06-175T 
observations at international mail branch facilities.13 Without an accurate 

estimate of the volume of importation of prescription drugs, federal 

agencies cannot determine the full scope of the importation issue. 

The Safety of Prescription 

Drug Imports Is Not 

Assured 

Regarding the safety of prescription drug imports, we report that FDA 

officials have said that they cannot provide assurance to the public 

regarding the safety and quality of drugs purchased from foreign sources, 

which are largely outside of their regulatory system. FDA officials also 

said that consumers who purchase prescription drugs from foreign-based 

Internet pharmacies are at risk of not fully knowing the safety or quality of

what they are importing. While some consumers may purchase genuine 

products, others may unknowingly purchase counterfeit products, expired 

drugs, or drugs that were improperly manufactured. 

In addition, we report on CBP’s and FDA’s limited analysis of the imported 

prescription drugs identified during special operations. The results of 

these efforts have raised questions about the safety of some of the drugs. 

 13FDA officials told us that FDA developed its estimate for Canadian drugs entering the 

country using (1) IMS Health estimates (IMS Health is a management consulting firm that 

provides information to pharmaceutical and health care industries) that 12 million 

prescriptions sold from Canadian pharmacies were imported into the United States in 2003

and (2) FDA’s experience during special operations at various locations from which it 

concluded that there appeared to be about 2.5 prescriptions in each package. According to

FDA officials, the estimate for other countries was an extrapolation using the estimated 5 

million packages from Canada in conjunction with FDA’s observations, likewise made 

during special operations, that 50 percent of the mail packages enter from countries other

than Canada. 

Page 17 GAO-06-175T 
For example, during a special operation in 2003 to identify and assess 

counterfeit and potentially unsafe imported drugs at four mail facilities, 

CBP and FDA inspected 1,153 packages that contained prescription 

drugs.14 According to a CBP report, 1,019, or 88 percent, of the imported 

drug products were in violation of the Federal Food, Drug, and Cosmetic 

Act or the Controlled Substances Import and Export Act. 

Consistent with these concerns, we report on the findings of our June 2004 

report in which we identified several problems associated with the 

handling, FDA approval status, and authenticity of 21 prescription drug 

samples we purchased from Internet pharmacies located in several foreign

countries—Argentina, Costa Rica, Fiji, Mexico, India, Pakistan, the 

Philippines, Spain, Thailand, and Turkey.15 Our work showed that most of 

the drugs, all of which we received via consignment carrier shipment or 

the U.S. mail, were unapproved for the U.S. market because, for example,

the labeling or the foreign manufacturing facility, methods, and controls 

were not reviewed by FDA. We observed during the site visits undertaken 

for our current report that in addition to some prescription drugs imported 

through the mail and carrier facilities not being shipped in protective 

 14According to CBP officials, packages shipped through four mail facilities were examined 

over a 3-day period. Approximately 100 parcels (each of which may have contained 

multiple drug products) per day per facility were selected based upon their country of

origin and CBP’s historical experience. 

15GAO-04-820 and GAO-04-888T. 

Page 18 GAO-06-175T 
packages, some drugs also lacked product identifications, directions for 

use, or warning labels. Furthermore, for some drugs, the origin and 

contents could not be immediately determined by CBP or FDA inspection. 

Our report also noted that federal agencies and professional medical and 

pharmacy associations have found that consumers of any age can obtain

highly addictive controlled substances from Internet pharmacies, 

sometimes without a prescription or consultation with a physician. Both 

DEA and ONDCP have found that the easy availability of controlled 

substances directly to consumers over the Internet has significant 

implications for public health, given the opportunities for misuse and 

abuse of these addictive drugs. In addition, the American Medical 

Association recently testified that Internet pharmacies that offer 

controlled substances without requiring a prescription or consultation 

with a physician contribute to the growing availability and increased use 

of addictive drugs for nonmedical purposes. 

My statement will now focus on the procedures and practices used at 

selected facilities to inspect and interdict prescription drugs unapproved 

for import. 

Highly Addictive 

Controlled Substances Are 

Widely Available via the 

Internet 

Some Targeted 

Packages Containing 

Prescription Drugs 

Are Interdicted, but 

Many Others Are Not 

Page 19 GAO-06-175T 
With regard to procedures and practices used at selected facilities to 

inspect and interdict prescription drugs unapproved for import, our report 

cites our July 2004 testimony in which we reported that CBP and FDA 

officials at selected mail and carrier facilities used different practices and 

procedures to inspect and interdict packages that contain prescription 

drugs. 16 While each of the facilities we visited targeted packages for 

inspection, the basis upon which packages were targeted could vary and 

was generally based on several factors, such as the inspector’s intuition 

and experience, whether the packages originated from suspect countries 

or companies, or were shipments to individuals. At that time, we also 

reported that while some targeted packages were inspected and 

interdicted, many others either were not inspected and were released to 

the addressees or were released after being held for inspection. FDA 

officials said that because they were unable to process the volume of 

targeted packages, they released tens of thousands of packages containing 

drug products that may violate current prohibitions and could have posed 

a health risk to consumers. 

New Procedures Should 

Encourage Uniform 

Practices, but They Still 

Allow Many Packages 

Containing Prescription 

Drugs to Be Released 

In August 2004, FDA issued standard operating procedures outlining how 

FDA personnel are to prioritize packages for inspection, inspect the 

packages, and make admissibility determinations of FDA-regulated 

 16See GAO, Prescription Drugs: Preliminary Observations on Efforts to Enforce the 

Page 20 GAO-06-175T 
pharmaceuticals imported into the United States via international mail. 

Under the procedures, CBP personnel are to forward to FDA personnel 

any mail items, from FDA’s national list of targeted countries and based on

local criteria,

17 that appear to contain prescription drugs. Deviations from 

the procedures must be requested by facility personnel and approved by 

FDA management. According to FDA officials, these procedures have been 

adopted nationwide. While the new procedures should encourage 

processing uniformity across facilities, many packages that contain 

prescription drugs are still released. Specifically, according to the 

procedures, all packages forwarded by CBP but not processed by FDA 

inspectors at the end of each workday are to be returned for delivery by

USPS to the recipient. However, according to the procedures, packages 

considered to represent a significant and immediate health hazard may be 

held over to the next day for processing. 

Our report cites CBP and FDA officials at two facilities who told us that 

the new procedures resulted in an increase in the number of packages 

CBP personnel refer to FDA. Officials at one facility estimated that CBP 

referrals have increased from approximately 500 to an average of 2,000 

packages per day. The FDA officials noted that the procedures did not 

resolve the heavy volume of prescription drug importation or FDA’s ability 

 Prohibitions on Personal Importation, GAO-04-839T (Washington, D.C.: July 22, 2004). 

17Local criteria can include other targeted countries and additional intelligence. 

Page 21 GAO-06-175T 
to deal with the volume, nor were they designed to do so. While the 

packages that are not targeted are released without inspection, so are 

many packages that are targeted and referred to FDA personnel. At one 

facility, FDA officials estimated that each week they return without 

inspection 9,000 to 10,000 of the packages referred to them by CBP. They

said these packages were given to USPS officials for delivery to the 

addressee. 

New CBP Controlled 

Substances Policy May 

Improve Interdiction 

Efforts, but Impact on 

Importation Is Unclear 

Regarding the procedures and practices used to inspect and interdict 

certain controlled substances, our report cites our July 2004 testimony in 

which we reported that CBP officials were to seize the illegally imported 

controlled substances they detected.18 However, at that time, some illegally 

imported controlled substances were not seized by CBP. For example, 

CBP officials at one mail facility told us that they experienced an 

increased volume of controlled substances and, in several months, had 

accumulated a backlog of over 40,700 packages containing schedule IV

substances. 

According to our report, CBP field personnel said they did not have the 

resources to seize all the controlled substances they detected. Officials 

said that the seizure process can be time-consuming, taking approximately 

 18GAO-04-839T. 

Page 22 GAO-06-175T 
1 hour for each package containing controlled substances. According to 

CBP officials, when an item is seized, the inspector records the contents of 

each package—including the type of drugs and the number of pills or vials 

in each package. If the substance is a schedule I or II controlled substance,

it is to be summarily forfeited without notice, after seizure. However, if it 

is a schedule III through V controlled substance, CBP officials are to notify 

the addressee that the package was seized19 and give the addressee an 

opportunity to contest the forfeiture by providing evidence of the 

package’s admissibility and trying to claim the package at a forfeiture 

hearing.20

Our report goes on to say that to address the seizure backlog and give CBP 

staff more flexibility in handling controlled substances, in September 2004, 

CBP implemented a national policy for processing controlled substances, 

schedule III through V, imported through the mail and carrier facilities. 

According to the policy, packages containing controlled substances should 

no longer be transferred to FDA for disposition, released to the addressee,

or returned to the sender. CBP field personnel are to hold the packages 

containing controlled substances in schedules III through V as unclaimed 

 19The seized package could also be submitted to ICE for possible investigation of the

addressee and the sender. 

20Since schedule I and schedule II controlled substances are subject to summary forfeiture 

without notice, there is no opportunity to contest the forfeiture of these drugs. 

Page 23 GAO-06-175T 
or abandoned property as an alternative to a seizure.21 According to a CBP 

headquarters official, processing a controlled substance as abandoned 

property is a less arduous process because it requires less information be 

entered into a database than if the same property were to be seized. Once 

CBP deems the controlled substance to be unclaimed property, the 

addressee is notified that he or she has the option to voluntarily abandon

the package or have the package seized. If the addressee voluntarily 

abandons the package or does not respond to the notification letter within 

30 days, the package will be eligible for immediate destruction. If the 

addressee chooses to have the package seized, there would be an 

opportunity to contest the forfeiture and claim the package, as described 

above. CBP also instituted an on-site data collection system at 

international mail and express carrier facilities to record schedule III 

through V controlled substances interdicted using this new process.22 CBP 

reported that from September 2004 to the end of June 2005, a total of 

approximately 61,700 packages of these substances were interdicted, 

 21Under the policy, unless accompanied by a valid DEA Import Permit or DEA Declaration, 

schedules I and II controlled substances are to be seized pursuant to 19 U.S.C § 

1595a(c)(1)(B) and processed in accordance with established seized asset procedures. 

22CBP officials emphasized that these data only include schedule III through V controlled 

substances interdicted through its new process and do not include those schedule III 

through V controlled substances seized. According to a CBP headquarters official, the 

number of interdictions made using the controlled substance policy implemented on

September 1, 2004, refers to single packages, because these detentions are almost all 

personal use quantities. In contrast, CBP seizure data for schedules III, IV, and V controlled 

substances are most likely commercial shipments and, therefore, could include multiple 

packages. 

Page 24 GAO-06-175T 
about 61,500 at international mail facilities and 200 at express carrier 

facilities. 

We report that generally, CBP officials we interviewed told us that the 

recent policy improved their ability to record information about and 

destroy schedule III through V controlled substances they detected. A CBP 

official at one facility said that the abandonment process is faster than the 

seizure process, as it requires much less paperwork. A CBP headquarters 

official told us that the abandonment process takes an inspector at a mail 

facility about 1 minute to process a package. He added that the new policy 

was intended to eliminate the backlog of schedule III through V controlled 

substances at the facilities. However, we also report that CBP officials in 

the field and in headquarters said that they do not know whether the new 

policy has had any impact on the volume of controlled substances illegally 

entering the country that reach the intended recipient. Generally, CBP 

officials do not know the extent of packages that contain controlled 

substances that are undetected and released. For example, CBP officials at 

one facility told us that they used historical data to determine the 

countries that are likely sources for controlled substances and target the 

mail from those countries. They do not know the volume of controlled 

substances contained in the mail from the nontargeted countries. A CBP 

official at another facility said that he believed the volume of controlled 

Page 25 GAO-06-175T 
substances imported through the facility had begun to decrease, but he 

had no data to support his claim. 

Packages Containing 

Prescription Drugs Can 

Bypass FDA Review at the 

Carrier Facilities 

According to our report, packages containing prescription drugs can also

bypass FDA inspection at carrier facilities because of inaccurate 

information about the contents of the package. Unlike packages at mail 

facilities, packages arriving at carrier facilities we visited are preceded by

manifests, which provide information from the shipper, including a 

description of the packages’ contents. While the shipments are en route, 

CBP and FDA officials are to review this information electronically and 

select packages they would like to inspect when the shipment arrives. FDA 

officials at two carrier facilities we visited told us they review the 

information for packages described as prescription drugs or with a related 

term, such as pharmaceuticals or medicine. CBP and FDA officials told us 

that there are no assurances that the shipper’s description of the contents

is accurate. The FDA officials at the carrier facilities we visited told us that 

if a package contains a prescription drug but is inaccurately described, it

would not likely be inspected by FDA personnel. 

Page 26 GAO-06-175T 
My statement will now focus on the three factors that our report identified 

as affecting federal agency efforts to enforce the prohibition on 

prescription drug importation for personal use through international mail 

and carrier facilities. 

Factors beyond 

Inspection and 

Interdiction 

Complicate Efforts to 

Enforce the 

Prohibitions on 

Personal Importation 

of Prescription Drugs 

The Volume of Imports 

Can Strain Federal

Resources 

In our report, we state that the current volume of prescription drug 

imports, coupled with competing agency priorities, has strained federal

inspection and interdiction resources allocated to the mail facilities. CBP 

and FDA officials told us that the recent increase in American consumers 

ordering drugs over the Internet has significantly contributed to increased

importation of these drugs through the international mail. CBP officials 

said that they are able to inspect only a fraction of the large number of 

mail and packages shipped internationally. FDA officials have said that the 

large volume of imports has overwhelmed the resources they have 

allocated to the mail facilities and they have little assurance that the 

available field personnel are able to inspect all the packages containing 

prescription drugs illegally imported for personal use through the mail. In 

addition, agencies have multiple priorities, which can affect the resources 

they are able to allocate to the mail and carrier facilities. For example, 

FDA’s multiple areas of responsibility include, among other things, 

Page 27 GAO-06-175T 
regulating new drug product approvals, the labeling and manufacturing 

standards for existing drug products, and the safety of a majority of food 

commodities and cosmetics, which, according to FDA officials, all go to 

FDA’s mission of protecting the public health while facilitating the flow of

legitimate trade. CBP’s primary mission is preventing terrorists and 

terrorist weapons from entering the United States while also facilitating 

the flow of legitimate trade and travel. DEA’s multiple priorities include 

interdicting illicit drugs such as heroin or cocaine, investigating doctors 

and prescription forgers, and pursuing hijackings of drug shipments. 

We also report on HHS and CBP assessments of resources needed to

address the volume of illegally imported drugs coming into the country. In

a 2004 report on the importation of prescription drugs, the Secretary of 

HHS stated that substantial resources are needed to prevent the increasing 

volume of packages containing small quantities of drugs from entering the 

country.23 The Secretary found that despite agency efforts, including those 

with CBP, FDA currently does not have sufficient resources to ensure 

adequate inspection of the current volume of personal shipments of 

 23HHS Task Force on Drug Importation, Report on Prescription Drug Importation, 

Department of Health and Human Services, December 2004. The Medicare Prescription 

Drug, Improvement, and Modernization Act of 2003 directed the Secretary of Health and 

Human Services, in consultation with appropriate government agencies, to conduct a study 

of the importation of drugs into the United States, including, according to the conference

report for the legislation, a review of the adequacy of federal agency resources to inspect 

and interdict drugs unapproved for import, and submit a report to Congress. Pub. L. No.

108-173, § 1122, 117 Stat. 2066, 2469 (2003), H.R. Conf. Rep. No. 105-39, at 833-34 (2003). 

Page 28 GAO-06-175T 
prescription drugs entering the United States. CBP is also in the early 

stages of assessing the resources it needs at the mail facilities to address 

the volume of controlled substance imports. However, CBP officials admit 

that an assessment of resource needs is difficult because they do not know 

the scope of the problem and the impact of the new procedures. A CBP 

official told us that CBP has a statistician working on developing estimates 

on the volume of drugs entering mail facilities; however, he was uncertain 

whether this effort would be successful or useful for allocating resources. 

Likewise, in March 2005, FDA officials told us that they had begun to 

gather from the field information on the imported packages it handles, 

such as the number of packages held, reviewed, and forwarded for further 

investigation. However, as of July 2005, they could not provide any data 

because, according to the officials, this effort was new and still being 

refined. 

Internet Pharmacies 

Challenge Law 

Enforcement Efforts 

According to our report, Internet pharmacies, particularly foreign-based 

sites, which operate outside the U.S. regulatory system, pose a challenge 

for regulators and law enforcement agencies. In an earlier 2004 report, we 

described how traditionally, in the United States, the practice of pharmacy 

is regulated by state boards of pharmacy, which license pharmacists and 

pharmacies and establish and enforce standards. To legally dispense a 

prescription drug, a licensed pharmacist working in a licensed pharmacy 

must be presented a valid prescription from a licensed health care 

Page 29 GAO-06-175T 
professional. The Internet allows online pharmacies and physicians to 

anonymously reach across state and national borders to prescribe, sell, 

and dispense prescription drugs without complying with state 

requirements or federal regulations regarding imports. 

In addition, we report that the nature of the Internet has challenged U.S. 

law enforcement agencies investigating Internet pharmacies, particularly 

foreign-based sites. Internet sites can easily be installed, moved, or 

removed in a short period of time. This fluidity makes it difficult for law 

enforcement agencies to identify, track, monitor, or shut down those sites 

that operate illegally. Moreover, investigations can be more difficult when 

they involve foreign-based Internet sites, whose operators are outside of 

U.S. boundaries and may be in countries that have different drug approval 

and marketing approaches than the United States has. For example, 

according to DEA officials, drug laws and regulations regarding controlled 

substances vary widely by country. DEA officials told us their enforcement 

efforts with regard to imported controlled substances are hampered by the 

different drug laws in foreign countries. Internet pharmacy sites can be

based in countries where the marketing and distribution of certain 

controlled substances are legal. Steroids, for example, sold over the 

Internet may be legal in the foreign country in which the online pharmacy 

is located. Federal agencies can also face challenges when working with 

foreign governments to share information or develop mechanisms for 

Page 30 GAO-06-175T 
cooperative law enforcement. For example, FDA officials have testified

that they possess limited investigatory jurisdiction over sellers in foreign 

countries and have had difficulty enforcing the law prohibiting 

prescription drug importation when foreign sellers are involved. A DEA 

official told us that it was difficult to convince some foreign governments 

that the illegal sale of prescription drugs over the Internet is a global

problem and not restricted to the United States. 

In our report, we also note that FDA and DEA officials told us that they 

work with commercial firms, including express carriers, credit card 

organizations, Internet providers, and online businesses to obtain 

information to investigate foreign pharmacies, but these investigations are

complicated by legal and practical considerations. FDA and DEA officials 

said that the companies have been willing to work with government 

agencies to stop transactions involving prescription drugs prohibited from 

import, and some have alerted federal officials when suspicious activity is

detected. However, officials also identified current legal and practical 

considerations that complicated obtaining information from organizations, 

such as credit card organizations. For example, according to FDA, DEA, 

Page 31 GAO-06-175T 
and ICE officials, credit card organizations24 and banks and other financial

institutions25 that issue credit cards will not provide to the agencies 

information about the parties involved in the transaction without a 

subpoena. Representatives from the credit card companies we contacted 

explained that these issues generally are resolved if the agency issues a 

properly authorized subpoena for the desired information.26

The Notification Process 

Challenges Enforcement 

Efforts 

We also report that FDA headquarters officials said that packages that 

contain prescription drugs for personal use that appear to be prohibited 

from import pose a challenge to their enforcement efforts because these 

packages cannot be automatically refused. Before any imported item is 

refused, the current law requires FDA to notify the owner or consignee 

that the item has been held because it appears to be prohibited and give 

the product’s owner or consignee an opportunity to submit evidence of

admissibility. If the recipient does not respond or does not present enough 

 24Two types of credit card organizations handle the four major U.S. credit cards. Credit

card associations, such as Visa and MasterCard, license their member banks to issue bank 

cards, authorize merchants to accept those cards, or do both. In contrast, full-service credit 

card companies, such as American Express and Discover, issue their own brands of cards

directly to customers and authorize merchants to accept those cards. See also GAO, Money 

Laundering: Extent of Money Laundering through Credit Cards Is Unknown, 

GAO-02-670 (Washington, D.C.: July 22, 2002), and Internet Gambling: An Overview of the 

Issues, GAO-03-89 (Washington, D.C.: December 2, 2002). 

25When banks and financial institutions, rather than the credit card company, have the

direct relationship with the merchants and credit cardholders, the former are the primary

source of transactional information needed for law enforcement purposes. 

26According to a DEA official, the majority of Internet drug sites used the payment systems

of the two associations we contacted. 

Page 32 GAO-06-175T 
evidence to overcome the appearance of inadmissibility, then the item can 

be returned to the sender, or in some cases destroyed. 

FDA officials told us that this requirement applies to all drug imports that 

are held under section 801(a) of the Federal Food, Drug, and Cosmetic 

Act. Nonetheless, they said that they believe this notification process is 

time consuming because each package must be itemized and entered into

a database; a letter must be written to each addressee; and the product 

must be stored. The process can take up to 30 days per import—and can 

hinder their ability to quickly handle packages containing prescription 

drugs prohibited from import. According to FDA investigators, in most 

instances, the addressee does not present evidence to support the drugs’ 

admissibility, and the drugs are ultimately provided to CBP or the U.S. 

Postal Service for return to sender. FDA headquarters officials told us that 

the Standard Operating Procedures, introduced in August 2004 and 

discussed earlier in this report, were an attempt to help FDA address the 

burden associated with the notification process because the procedures 

were designed to focus resources on packages containing drugs 

considered to be among the highest risk. 

Our report further indicates that FDA and the Secretary of HHS have 

raised concerns about FDA’s notification process, noting that it is timeconsuming and resource intensive, in testimony before Congress, but did 

Page 33 GAO-06-175T 
not propose any legislative changes to address the concerns identified. In 

May 2001, FDA’s Acting Principal Deputy Commissioner wrote a 

memorandum to the Secretary of HHS expressing concern about the 

growing number of drugs imported for personal use and the dangers they 

posed to public health. The memorandum explained that because of the 

notice and opportunity to respond requirements, detaining and refusing 

entry of mail parcels was resource intensive. The Acting Principal Deputy 

Commissioner proposed, among other things, the removal of the 

requirement that FDA issue a notice before it could refuse and return 

personal use quantities of FDA-regulated products that appear violative of 

the Food, Drug, and Cosmetic Act. He noted that removal of the 

notification requirement would likely require legislation, but without this 

change, FDA could not effectively prohibit mail importation for personal 

use. As of July 2005, according to FDA officials and an HHS official, the

Secretary had not responded with a specific legislative proposal to change 

FDA’s notification requirement. FDA officials said that there are some 

complicating issues associated with eliminating the notification 

requirement; for example, the importance of providing due process, which 

basically gives individuals the opportunity to present the case as to why 

they should be entitled to receive the property (e.g., prescription drugs 

that they ordered from a foreign source), and/or the extent the law should 

be changed to cover all imported prescription drugs and other products. In 

Page 34 GAO-06-175T 
addition, USPS indicated that any discussion of options to expedite the 

processing and disposition of prescription drugs must consider 

international postal obligations, specifically the requirements of the 

Universal Postal Union (UPU). FDA officials said that currently, the 

notification requirement also applies to large commercial quantities of 

prescription drugs and other nonpharmaceutical products for which the 

requirement is not a problem. They said it has become a burden only 

because FDA and CBP are overwhelmed with a large volume of small 

packages. 

Furthermore, we report that FDA officials said that they have considered 

other options for dealing with this issue, such as summarily returning each

package to the sender without going through the process. However, they 

said that the law would likely need to be changed to allow this, and, as 

with the current process, packages that are returned to the sender could,

in turn, be sent back by the original sender to go through the process 

again. They said that another option might be destruction, but they were 

uncertain whether they had the authority to destroy drugs FDA intercepts; 

they indicated that the authority might more likely lie with CBP. 

Regardless, FDA officials said that whatever approach was adopted, FDA 

might continue to encounter a resource issue because field personnel 

would still need to open and examine packages to ascertain whether they 

contained unapproved prescription drugs. 

Page 35 GAO-06-175T 
My statement will now focus on efforts federal agencies have undertaken 

to coordinate the enforcement of the prohibitions on personal importation 

of prescription drugs. 

Federal Efforts to 

Coordinate Law 

Enforcement 

Activities Could 

Benefit from a 

Strategic Framework 

Federal Agencies Have 

Recently Begun to 

Coordinate Efforts to 

Focus on Prescription 

Drugs Imported for 

Personal Use 

According to our report, since 1999, federal law enforcement and 

regulatory agencies have organized various task forces and working 

groups to address issues associated with purchasing prescription drugs 

over the Internet; however, recent efforts have begun to focus particular 

attention on imported prescription drugs. For example, according to an 

FDA official, many of FDA’s efforts, started in 1999, focused on Internet 

pharmaceutical sales by illicit domestic pharmacies and the risks 

associated with purchasing those drugs, rather than drugs that are being 

imported from foreign countries. As our report discusses, more recent 

efforts have focused on prescription drugs entering international mail and 

express carrier facilities. 

In January 2004, the CBP Commissioner initiated an interagency task force 

on pharmaceuticals, composed of representatives from CBP, FDA, DEA, 

ICE, and ONDCP as well as legal counsel from the Department of Justice.

According to the Commissioner, the proposal to create the task force was 

prompted by “intense public debate and congressional scrutiny, which has 

Page 36 GAO-06-175T 
resulted in increasing pressure being applied to regulatory and law 

enforcement agencies to develop consistent, fair policies” to address 

illegal pharmaceuticals entering the United States. The Commissioner 

proposed that the task force achieve five specific goals, and according to a 

CBP official, five working groups were established to achieve these goals. 

Figure 1 shows the task force goals, the five working groups, and the goals 

of each working group. 

Page 37 GAO-06-175T 
Figure 1: Interagency Pharmaceutical Task Force and Working Group Goals 

Source: GAO analysis of CBP documents.

Interagency Pharmaceutical Task Force

Working group

Mail and express 

consignment operator 

facilities procedures

Increasing public 

awareness

Working cooperatively 

with industry

Targeting/data research

Legal

Working group’s goal

Develop standardized policies and 

procedures for use at mail and express 

consignment operative facilities and assess 

existing resources at these locations.

Disseminate the central message that 

imported pharmaceuticals may be dangerous 

to the health and safety of U.S. citizens and 

residents. The audience is Internet purchasers 

of medication and individual travelers.

Develop and utilize industry partnerships 

to address current pharmaceutical 

importation issues.

Improve information sharing and 

targeting criteria and identify criteria for 

future enforcement operations and 

cooperative efforts.

Advise the task force on legal/regulatory 

issues related to pharmaceutical importations. 

 Task force goals

A mutually agreed upon strategy for 

enforcement, interdiction, and disposition of 

unlawful pharmaceuticals entering into the 

United States.

Proposals for joint enforcement operations at 

ports of entry. 

Recommendations for appropriate statutory 

or regulatory changes to increase the 

effectiveness of enforcement efforts.

Mutually agreed upon policies relative to 

unauthorized importations.

Agreements for the commitment of resources 

to carry out the strategy and polices that are 

developed by the task force.

CBP officials and other members of the task force provided examples of 

activities being carried out or planned by task force working groups. For 

example, the working group on mail and express consignment operator 

facilities procedures has carried out special operations at five 

international mail and three express carrier facilities to examine parcels 

suspected of containing prohibited prescription drugs over specific 

periods of time, such as 2 or 3 days. While similar operations have 

occurred since 2000, a CBP official told us that those conducted under the 

Page 38 GAO-06-175T 
task force are multiagency efforts; they are expected to continue during 

the remainder of 2005 at all of the remaining mail facilities and some of the 

carrier facilities. Our report describes activities of the other working 

groups. 

In addition, we report that the task force members are working with 

ONDCP to address the importation of controlled substances through 

international mail and carrier facilities. In October 2004, ONDCP issued a 

plan for addressing demand and trafficking issues associated with certain 

man-made controlled substances—such as pain relievers, tranquilizers, 

and sedatives.27 Among other things, ONDCP recommended that DEA, 

CBP, ICE, State Department, National Drug Intelligence Center, and FDA 

work with USPS and private express mail delivery services to target illegal 

mail order sales of chemical precursors, synthetic drugs, and 

pharmaceuticals, both domestically and internationally. ONDCP officials 

said that a multiagency working group is meeting to discuss what can be 

done to confiscate these controlled substances before they enter the 

country. 

 27ONDCP, National Synthetic Drugs Action Plan: The Federal Government Response to

the Production, Trafficking, and Abuse of Synthetic Drugs and Diverted Pharmaceutical

Products (Washington D.C.; October 2004). According to ONDCP, the Action Plan is to 

provide a blueprint for action under the President’s National Drug Control Strategy and 

“focuses primarily on illicitly manufactured synthetic drugs which are not of primarily 

organic origin” and “selected pharmaceutical products which are sometimes diverted from

legitimate commerce.” 

Page 39 GAO-06-175T 
Finally, we report that USPS is exploring what additional steps it can take

to further help the task force. USPS officials said that they proposed, 

during a July 2004 hearing, the possibility of cross-designating U.S. Postal

Inspectors with Customs’ authority so that Postal Inspectors can conduct 

warrant-less searches, at the border, of incoming parcels or letters 

suspected of containing illegal drugs. According to USPS officials, such 

authority would facilitate interagency investigations. They said that their 

proposal has yet to be finalized with CBP. In addition, internationally, 

USPS has drafted proposed changes to the U.S. listing in the Universal 

Postal Union List of Prohibited Articles.28 This action is still pending. 

A Strategic Framework 

Would Further Enhance 

Task Force Efforts 

In our report, we state that although the task force has taken positive steps 

toward addressing issues associated with enforcing the laws on personal 

imports, it has not fully developed a strategic framework that would allow 

the task force to address many of the challenges we identify in this report. 

Our review showed that the task force has already begun to establish some 

elements of a strategic framework, but not others. For example, the 

Commissioner’s January 2004 memo laid out the purpose of the task force 

and why it was created. However, it has not defined the scope of the 

 28The Universal Postal Union List of Prohibited Articles is a listing of articles prohibited for 

importation into the United States, as well as other member countries of the UPU. The 

listing is shared with foreign postal administrations to enable them to educate their 

customers on country prohibitions for international mail. 

Page 40 GAO-06-175T 
problem it is trying to address because, as discussed earlier, CBP and FDA 

have yet to develop a way to estimate the volume of imported prescription 

drugs entering specific international mail and carrier facilities. In addition, 

while the task force and individual working groups have goals that state 

what they are trying to achieve, the task force has not established 

milestones and performance measures to gauge results. Furthermore, the 

task force has not addressed the issue of what its efforts will cost so that it

can target resources and investments, balancing risk reduction with costs 

and considering task force members’ other law enforcement priorities. 

Instead, according to a CBP official, working group projects are done on

an ad hoc basis wherein resources are designated for specific operations. 

Carrying out enforcement efforts that involve multiple agencies with 

varying jurisdictions is not an easy task, especially since agencies have

limited resources and often conflicting priorities. According to our report, 

the challenges we identify could be more effectively addressed by using a 

strategic framework that more clearly defines the scope of the problem by 

estimating the volume of drugs entering international mail and carrier 

facilities, establishes milestones and performance measures, determines 

resources and investments needed to address the flow of imported drugs 

entering the facilities and where those resources and investments should 

be targeted, and evaluates progress. Advancing such a strategic framework 

could establish a mechanism for accountability and oversight. Our report 

Page 41 GAO-06-175T 
acknowledges that such a strategic framework needs to be flexible to 

allow for changing conditions and could help agencies adjust to potential 

changes in the law governing the importation of prescription drugs for 

personal use. 

While acknowledging the complexities of enforcing the laws governing 

prescription drug imports for personal use, including the involvement of 

multiple agencies with various jurisdictions and differing priorities, our 

report concludes that current inspection and interdiction efforts at the 

international mail branches and express carrier facilities have not 

prevented the reported substantial and growing volume of prescription 

drugs from being illegally imported from foreign Internet pharmacies into 

the United States. CBP and other agencies have taken a step in the right 

direction by establishing a task force designed to address many of the 

challenges discussed in this report. However, a strategic framework that 

facilitates comprehensive enforcement of prescription drug importation 

laws and measures results would provide the task force with an

opportunity to better focus agency efforts to stem the flow of prohibited 

prescription drugs entering the United States. In addition to the issues 

addressed by the task force, FDA has also expressed continuing concern 

to Congress that it encounters serious resource constraints enforcing the 

law at mail facilities because packages containing personal drug imports 

must be handled in accordance with FDA’s time-consuming and resourceGAO Conclusions, 

Recommendations, 

and Agency 

Responses 

Page 42 GAO-06-175T 
intensive notification process. FDA has stated that it cannot effectively 

enforce the law unless the requirement to notify recipients is changed. 

Accordingly, to help ensure that the government maximizes its ability to 

enforce laws governing the personal importation of prescription drugs, our 

report recommends that the CBP Commissioner, in concert with ICE, 

FDA, DEA, ONDCP, and USPS, develop and implement a strategic 

framework for the task force that would promote accountability and guide 

resource and policy decisions. At a minimum, this strategic framework 

should include 

• establishment of an approach for estimating the scope of the problem, 

such as the volume of drugs entering the country through mail and 

carrier facilities; 

• establishment of objectives, milestones, and performance measures 

and a methodology to gauge results; 

• determination of the resources and investments needed to address the 

flow of prescription drugs illegally imported for personal use and 

where resources and investments should be targeted; and 

• an evaluation component to assess progress, identify barriers to 

achieving goals, and suggest modifications. 

Page 43 GAO-06-175T 
In view of FDA’s continuing concern about the statutory notification 

requirement and its impact on enforcement, our report also recommends 

that the Secretary of HHS assess the ramifications of removing or 

modifying the requirement, report on the results of this assessment, and, if 

appropriate, recommend changes to Congress. 

In commenting on our report, DEA and ONDCP generally agreed with our 

recommendation that the CBP task force develop a strategic framework. 

DEA agreed that such a framework needs to be flexible to allow for 

changing conditions and said DEA will, in concert with other task force 

agencies, support the CBP Commissioner’s strategic framework for the 

interagency task force. DHS generally agreed with the contents of our 

report and said that CBP is convening a task force meeting to discuss our 

recommendation. While generally concurring with our recommendation 

for a strategic framework, HHS questioned the need to include an 

approach for estimating the volume of unapproved drugs entering the 

country, because it believed its current estimates are valid. HHS also said 

our statement that the task force agencies could develop statistically valid 

volume estimates and realistic risk-based estimates of the number of staff 

needed to interdict parcels at mail facilities did not recognize FDA’s 

current level of effort at these facilities relative to its competing priorities. 

We believe that developing more systematic and reliable volume estimates 

might position agencies to better define the scope of the problem so that 

Page 44 GAO-06-175T 
decision makers can make informed choices about resources, especially in

light of competing priorities. Regarding our recommendation to assess the 

ramifications of removing or modifying FDA’s statutorily required 

notification process, HHS generally agreed and stated that it intended to 

pursue an updated assessment. USPS did not state whether it concurred 

with our recommendations, but it noted that discussions of options to 

expedite the processing and disposition of prescription drugs must 

consider international postal obligations. 

Mr. Chairman, this concludes my prepared testimony. I would be happy to

respond to any questions you or other members of the committee may 

have at this time. 

GAO Contacts and Staff Acknowledgments 

For further information about this testimony, please contact me at (202) 

512-8816. John F. Mortin, Leo M. Barbour, Frances A. Cook, Katherine M. 

Davis, Michele C. Fejfar, and Barbara A. Stolz made key contributions to 

this statement. 

Page 45 GAO-06-175T 
Page 1 GAO-06-175T 

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